n.a. 26040XARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04048551092057), received between Apr 7, 2017 and Nov 25, 2025 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED: "THE CERAMIC TIP OF THIS SHEATH BROKE APART FROM THE METAL WHILE IN USE INSIDE A PATIENT'S BLADDER. THE SURGEON WAS ABLE TO QUICKLY EXTRACT THE SHEATH ITSELF, AS WELL AS THE SEPARATED CERAMIC TIP. NO PATIENT INJURY OR IMPACT DUE TO THIS MALFUNCTION." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647601 ↗
• InjuryJun 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A OPERATIVE HYSTEROSCOPY ON (B)(6) 2024, THE BEAK OF THE INNER SHEATH BROKE INSIDE A FEMALE PATIENT. NO PATIENT INJURY WAS REPORTED, AND THEY WERE ABLE TO COMPLAINT THE PROCEDURE WITHOUT ANY OTHER ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19563105 ↗
• InjuryJun 18, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A OPERATIVE HYSTEROSCOPY ON (B)(6) 2024, THE BEAK OF THE INNER SHEATH BROKE INSIDE A FEMALE PATIENT. NO PATIENT INJURY WAS REPORTED, AND THEY WERE ABLE TO COMPLAINT THE PROCEDURE WITHOUT ANY OTHER ISSUE.

  Patient problems: Foreign Body In Patient; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563018 ↗
• InjurySep 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MANUFACTURER INCIDENT REPORT (B)(4) RECEIVED FROM THE FACTORY IN GERMANY: IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT 26040XA - INNER SHEATH, FIXED, FOR 26040SL. ACCORDING TO THE COMPLAINT DESCRIPTION RECEIVED BY THE CUSTOMER, THE INNER SHEATH OF A HYSTEROSCOPE 26040XA WAS DISASSEMBLED DURING SURGERY AND THE CERAMIC TERMINAL FELL INSIDE THE UTERUS. THIS HAPPENED DURING OPERATIVE HYSTEROSCOPY. THE INCIDENT CAUSED A PROLONGATION OF THE INTERVENTION BY 4 HOURS (WHICH NORMALLY LASTS 15 MINUTES) RESULTING IN THE PRECAUTIONARY HOSPITALIZATION OF THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 15439600 ↗
• MalfunctionAug 31, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  DURING A PROCEDURE THE CERAMIC TIP FRACTURED. THE PIECE WAS ABLE TO RETRIEVED. NO HARM TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327756 ↗
• MalfunctionJun 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE THE INSTRUMENT DETACHED. IMAGING WAS REQUIRED, NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 14695510 ↗
• MalfunctionFeb 28, 2018Material Separation; Dent in Material; Material Separation; Dent in Material

  ALLEGEDLY, DURING A HOLAD UROLOGY PROCEDURE, THE CERAMIC BEAK OF THE INNER RESECTOSCOPE SHEATH BROKE OFF INSIDE THE PATIENT'S BLADDER AND WAS RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7303290 ↗
• MalfunctionJan 5, 2018Break

  ALLEGEDLY, DURING A CYSTOSCOPY, LASER LITHOTRIPSY BLADDER STONE AND CHANGE OF SUPRAPUBIC CATHETER PROCEDURE, THE TIP OF THE INNER RESECTOSCOPE SHEATH BROKE INTO PIECES. "THE PHYSICIAN WAS ABLE TO RETRIEVE MISSING PIECES, EXCEPT FOR A VERY MINUTE PIECE OF LESS THAN 2 MM, THROUGH THE CYSTOSCOPE". THE BLADDER WAS THOROUGHLY IRRIGATED BY THE DOCTOR. THE PATIENT WAS DISCHARGED ON THE DAY OF THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7170271 ↗
• MalfunctionApr 7, 2017Material Separation; Material Separation

  ALLEGEDLY, DURING A CYSTO PROCEDURE THE DOCTOR NOTED THAT A SMALL PIECE OF CERAMIC BEAK BROKE OFF THE DISTAL END OF THE INSTRUMENT AND FELL INTO THE PATIENT. THE DOCTOR IMMEDIATELY REMOVED THE BROKEN PIECE AND THE PROCEDURE WAS COMPLETED WITH NO DELAY. THE HOSPITAL REPORTED THAT THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6472579 ↗